Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Behavioral: Peer Mentoring |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (CEPACT) |
- Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]Measured by change in HbA1c
- Blood Pressure [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
- Diabetes Quality of Life [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]Diabetes Distress Scale
- Depression Symptoms [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]As measured by the Patient Health Questionnaire-2
- Direct LDL blood levels [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 360 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Usual Care
Enrolled in two different time frames. No interventions will be provided to this arm. They will complete all planned surveys. Interviews, and blood draws (baseline, 6 months, and 12 months).
|
|
|
Experimental: Peer Mentoring
Participants in this arm will be mentored for 6 months by a veterans who was once in poor control but is now in good control. They will then become a mentor for 6 months.
|
Behavioral: Peer Mentoring
Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control. Arm 3: Will receive peer mentoring from former mentees. |
|
Experimental: Peer Mentoring FFM (from former mentee)
Participants in this arm will be mentored by the former mentee for 6 months and will be followed for an additional 6 most after the completion of the active intervention.
|
Behavioral: Peer Mentoring
Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control. Arm 3: Will receive peer mentoring from former mentees. |
Detailed Description:
The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control in a mixed race population of poorly controlled diabetic veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) determine the cost-effectiveness of peer mentoring as implemented in this study. Secondary objectives include: (1) assess the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health; and (2) assess the effects of the program on other important health outcomes for diabetics including blood pressure, low density lipoprotein (LDL) levels, diabetes quality of life, and depression.
This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, direct LDL, diabetes quality of life and depression. We will also perform a cost-effectiveness analysis of the different interventions compared to the control arm. We will take the perspective of the payer.
The trial has 3 arms: 1. usual care; 2. peer mentoring where mentors are veterans who were once in poor control but are now in good control; and 3. peer mentoring where the mentoring comes from former mentees. Qualitative interviews with participants will provide an additional layer of insight. Determining how best to create sustainable peer mentoring models will create for the VA a new powerful tool with the potential for improving chronic disease outcomes and reducing disparities, and it will demonstrate VA leadership in creating models exportable to other settings.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All participants must have a diagnosis of Type 2 diabetics.
- Diabetes began after age 30
- Mentees: Have an HbA1c > 8% on 2 different occasions in the course of 24 months, with at least measure within 3 months of enrollment
- Mentors: Have an HbA1c of > 8% in the past 3 years and an HbA1c < (or equal to) 7.5% within 3 months of enrollment
Exclusion Criteria:
- Does not speak English
- Unable to understand consents
- Severe speech impediment
- over the age of 75
Contacts and Locations| Contact: Kirsten M Rogers, BA | 215-823-5800 ext 7929 | rogerski@sas.upenn.edu |
| Contact: Jennifer Gutierrez, MS | 215-823-5800 ext 7417 | jennifer.gutierrez@va.gov |
| United States, Pennsylvania | |
| Philadelphia Veterans Affairs Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Kirsten M Rogers, BA 215-823-5800 ext 7929 rogerski@sas.upenn.edu | |
| Contact: Jennifer Gutierrez, MS 215-823-5800 ext 7417 jennifer.gutierrez@va.gov | |
| Principal Investigator: Judith A Long, MD | |
| Principal Investigator: | Judith A Long, MD | Philadelphia Veterans Affairs Medical Center |
More Information
Publications:
| Responsible Party: | Judith Long, MD, Principal Investigator, Philadelphia Veterans Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT01651117 History of Changes |
| Other Study ID Numbers: | 01373 |
| Study First Received: | July 24, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Philadelphia Veterans Affairs Medical Center:
|
Diabetes Mellitus Mentors Glucose control |
Hemoglobin A, Glycosylated Randomized Controlled Trial Veterans |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013